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From Health Law Daily, December 3, 2014

Patient feels the burn, FDC Act preempts products liability challenge

By Bryant Storm, J.D.

The Eighth Circuit affirmed a district court’s dismissal of a products liability action brought by a patient alleging injuries caused by a generic drug manufacturer’s generic version of the brand-name gastroesophageal reflux drug, Reglan®. The court reasoned that the injured patient’s state law claims were preempted by federal law because they attempted to create safety and labeling requirements for the generic drug that conflicted with the federal regulatory structure of the Food, Drug, and Cosmetic Act (FDC Act) (21 U.S.C. § 301) (Brinkley v. Pfizer, Inc., December 2, 2014, Riley, W.).

Labeling. Under the FDC Act, the FDA permits generic drug manufacturers to manufacture generic versions of brand name drugs when the manufacturer can demonstrate that the drugs are the “same as” the brand name drug in design and labeling. The FDA requires that the dosage, active ingredients, route of administration, strength, and labeling be identical to the brand name drug that the generic is based upon. Due to this structure, generic manufacturers are not permitted to alter their generic labels or to issue additional warnings regarding the safety of their generic drug. In order to protect generic manufacturers, federal law preempts any state law attempt to require generic manufacturers to take on additional labeling, design or warning requirements that conflict with the strict requirements of the FDC Act.

Injury. Shirley Brinkley was prescribed the brand-name drug Reglan to treat gastroesophageal reflux disease. Brinkley’s pharmacists substituted Reglan for a generic equivalent of metoclopramide, which was manufactured by Pliva. In 2004, Schwarz Pharma, Inc., the manufacturer of Reglan at the time, issued and was granted a request to add additional warnings to Reglan’s label. Specifically, the new warnings include a statement that use of Reglan should not exceed 12 weeks. Pliva did not implement those additional labels onto the generic labeling and Brinkley regularly took the generic between 2002 and 2007. Brinkley’s physician allegedly relied on statements from the brand manufacturer regarding the safety of Reglan when prescribing Reglan. Brinkley then developed tardive dyskensia, a neurological condition, which she contends was caused by her prolonged use of the generic version of the drug.

Lawsuit. In March 2010, Brinkley brought a products liability action against the two companies who, at different times, manufactured Reglan: Schwarz, Pfizer, Inc., and Wyeth, LLC, as well as Pliva, the generic manufacturer. Following Brinkley’s filing of a second amended complaint raising additional state law causes of action against Pliva, the generic manufacturer moved for judgment on the pleadings contending that Brinkley’s claims were preempted by federal law. The district court dismissed Brinkley’s claims and Brinkley appealed.

Label change. On appeal before the Eighth Circuit, Brinkley contended that the district court erred when it dismissed her claims arising from “Pliva’s failure to incorporate the 2004 label change, a non-warning design defect, and breach of implied warranty.” With regard to the label change, the appellate court held that because Brinkley’s physician relied on the prescribing information issued by the brand manufacturers regarding the safety of Reglan, the physician served as a “learned intermediary” and broke the link between Brinkley and any alleged failure of the generic manufacturer to update its label.

Brand and generic. The court further reasoned that even if Brinkley’s physician was not aware of the additional warnings, Brinkley failed to demonstrate that the inadequate warnings were what caused the physician to prescribe the generic metoclopramide. Because the physician prescribed Reglan and relied on information from Reglan in making the decision to prescribe the brand name drug, the court reasoned that generic manufacturer, Pliva, did nothing to influence Brinkley’s physician’s decision to prescribe Reglan. The court also emphasized that, to the degree Brinkley challenged the content of the labeling, those claims were preempted by state law because federal law would not allow for state law claims that apply additional labeling requirements on generic drug manufacturers.

Design. The court held that both Brinkley’s design defect and breach of implied warranty claims were also preempted by federal law because there was no way Pliva could have acted to make the design of the product safer without breaching the requirements of the FDC Act. The court reasoned that Brinkley’s claims sought to impose additional and different design requirements on the generic drug manufacturer. In other words, the court reasoned that Brinkley could not demonstrate an action that Pliva could have taken, which would have been compatible with an alternative design and the FDC Act’s sameness requirements. The court held that the same was true of Brinkley’s breach of implied warranty claim because it essentially attacked Pliva’s design and labeling for a product where the manufacturer had no control over the design or the labeling because it was a generic drug.

The case number is 13-3663.

Attorneys: Benjamin A. Bertram (Bertram & Graf) for Shirley J. Brinkley. Matthew V. Brammer (Ulmer & Berne), and Michael D. Shumsky (Kirkland & Ellis) for Pliva, Inc.

Companies: Pfizer, Inc.; Wyeth, LLC; Schwarz Pharma, Inc.; Pliva, Inc.

MainStory: TopStory CaseDecisions PreemptionNews GenericDrugNews FDCActNews PrescriptionDrugNews PLDrugNews SafetyNews LabelingNews ArkansasNews IowaNews MinnesotaNews MissouriNews NebraskaNews NorthDakotaNews SouthDakotaNews

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